Prescription drug · NDA
Olinvyk (Oliceridine) NDC 71308-021
Oliceridine 2 mg/2mL · Injection, Solution · Intravenous · Trevena, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71308-021-10 | 71308002110 | 10 VIAL, SINGLE-DOSE in 1 CARTON (71308-021-10) / 2 mL in 1 VIAL, SINGLE-DOSE (71308-021-01)Marketed from Aug 7, 2020 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Olinvyk
- Generic name (nonproprietary)
- oliceridine
- Active ingredients
- Oliceridine — 2 mg/2mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Labeler
- Trevena, Inc.NDC labeler code 71308
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 210730
- Marketing start
- Listing expires
- DEA schedule
- CII
- Identifiers
- Product ID 71308-021_43ecba1a-fa95-40e0-a383-8f9cdb6ad6b6SPL ID 43ecba1a-fa95-40e0-a383-8f9cdb6ad6b6SPL set ID ce167984-8b9d-40b7-84ce-d0f33fff1eaaRxCUI 2392234, 2392239, 2392242, 2392243, 2392244, 2392245UNII MCN858TCP0UPC 0371308011105, 0371308021104
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N471308002110followed by a unit qualifier and the quantityPackage 71308-0021-10. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
OLINVYK is indicated in adults for the management of acute pain severe enough to require an intravenous opioid analgesic and for whom alternative treatments are inadequate. Limitations of Use Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration [see Warnings and Precautions ( 5.1 )] , and persist over the course of therapy, reserve opioid analgesics, including OLINVYK, for use in patients for whom alternative treatment options are ineffective, not management of pain. The cumulative total daily dose should not exceed 27 mg, as total daily doses greater than 27 mg may increase the risk for QTc interval prolongation [see Warnings and P…
Excerpt only. Read the full label for complete information.
About NDC 71308-021
- What is NDC 71308-021?
- 71308-021 is the product NDC for Olinvyk (oliceridine), Oliceridine 2 mg/2mL injection, solution, listed with the FDA by Trevena, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Olinvyk (Oliceridine).
- What is the active ingredient?
- Oliceridine.
- Who is the labeler?
- Trevena, Inc., NDC labeler code 71308. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Olinvyk?
- 1 other product NDC are listed under this name. See all Olinvyk NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Olinvyk products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Olinvykoliceridine | Oliceridine 1 mg/mL | Injection, SolutionIntravenous | Trevena, Inc. | 71308-011 | 71308-0011-10 |
Other NDCs under NDA 210730
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Olinvykoliceridine | Oliceridine 1 mg/mL | Injection, SolutionIntravenous | Trevena, Inc. | 71308-011 |